Active — Not RecruitingNot Applicable

Low Intensity Shockwave Therapy for Erectile Dysfunction

United States338 participantsStarted 2020-06-01

Plain-language summary

Low-intensity shockwave therapy (LiSWT) has been deemed "a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation" by the European Society of Sexual Medicine. In a similar manner, the Sexual Medicine Society of North America and American Urological Association have put forth guideline statements recommending additional investigation of this treatment modality.2 The current clinical armamentarium only treats the symptoms of erectile dysfunction without improving upon the underlying pathophysiology. LiSWT has been used effectively in musculoskeletal disorders and cardiovascular applications. Animal studies have shown improvements in angiogenesis and stem cell recruitment in other systems (cardiac and musculoskeletal) using shockwave therapy. It has been used to treat erectile dysfunction since 2010 and is widely used in Europe and throughout the world. It is gaining widespread acceptance in the United States with a relative paucity of data in regards to its effectiveness. While the majority of studies and meta-analyses show improvements in standardized erectile dysfunction questionnaires (IIEF/SHIM-Sexual Health Inventory in Men, International Index of Erectile Function-5) the durability remains unknown and many have lacked a sham-arm. In addition, many studies have failed to assess a population of men who have highly prevalent erectile dysfunction, those men undergoing prostate cancer treatment. This is a prospective, randomized, single blind, sham-controlled clinical study aimed to evaluate the safety and efficacy of low-intensity shockwave therapy (LiSWT) on symptomatic ED patients in three distinct patient populations. LiSWT has shown the potential to improve baseline erectile function but requires further study, which is the aim of this investigation.

Who can participate

Age range30 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The patient must be willing and able to provide informed consent. * The patient is a male between \>30 and \<80 years of age. * PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 2 weeks before baseline IIEF. * Baseline IIEF-EF score ≥ 8 and ≤21. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF. * Testosterone level \> 300 ng/dL. This includes patients on therapeutic testosterone therapy. * If diabetic, HgbA1C level ≤ 7.5% within 3 months prior to enrollment. * Men who have undergone radical prostatectomy ≥ 12 months ago * Men who have undergone radiation therapy, either brachytherapy or external bean therapy ≥ 12 months ago Exclusion Criteria: * History of extensive pelvic surgery ever. * Past radiation therapy of the pelvic region within 12 months prior to enrollment. * Recovering from any non-prostate related cancer within 12 months prior to enrollment. * Neurological disease which affects erectile function at the discretion of the investigator. * Anatomical malformation of the penis, including Peyronie's disease. * Testosterone level \<300 within 3 month prior to enrollment. * HgbA1C level \> 7.5% within 3 month prior to enrollment. * History of spinal cord injury. * Recovering from any non-prostate cancer malignancy within 12 months prior to enrollment.

What they're measuring

Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment

Timeframe: 1 month

Trial details

NCT IDNCT04434352

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-10